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Curs 3 CB Metodologia Cercetarii

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4 vizualizări98 paginiCurs 3 CB Metodologia Cercetarii

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Colectarea datelor

Strategii de masurare

Obiective

Stabilirea tipurilor de variabile

Surse IT de date

Identifica si localizeaza seturile corecte de date

In institutie

In afara institutiei

Strategii de masurare

Analiza, interpretarea si raportarea rezultatelor

Foloseste programele pentru analize statistice simple si

prezentarea grafica a rezultatelor

Interpreteazarezultatele

Tipuri de variabile

Variabile de

confuzie*

Predictor*

Rezultat

Modificatori ai efectului*

*Considerate general ca expunere la factori de risc

Studii fara variabile

opinii / comentarii, rapoarte review

Studii descriptive

Studii cu 2 variabile

Experimente

Studii observationale

Meta-analize si review-uri sistematice

Studii clinice

Descriptive

Analitice

Experimentale

Observationale

Cohorta

Caz-control

Cross-sectional

Variabile

Variabila predictor

(independenta)

Variabila rezultat

(dependenta)

Metode de tratament sustinute de

dovezi clinice si de cercetare.

Necesita integrarea celor mai bune

dovezi din cercetare pentru diagnostic

si tratament cu experienta clinica.

Ia in considerare ce este optim pentru

fiecare pacient precum si preferintele

acestuia.

Realitatea

Cercetarea asupra eficientei de tratament

face subiectul unui numar mic de articole.

Evidence based medicine este considerat un

concept ce foloseste baze de date inclusiv

studii sistematice de caz pentru a ghida

interventii terapeutice.

Dovezile trebuie evaluate intr-un context

terapeutic efectiv, Ce tip de interventie

capata sens pentru mine ca practician?

Clinical Questions

What is the best choice of therapy

for my patient?

Is this program theoretically sound?

Does this therapy program work?

How long with the therapy take?

Where do I go from here?

Clinicians

are on the front line

have necessary clinical expertise

know their patients well

are naturally scientific thinkers

are well-versed in data collection

know how to look for outcomes

Baseline Measurements

A baseline is a measure of response

rates in the absence of treatment

Baselines

Establish a need for treatment

Document improvement

Allow us to modify if we dont see

improvement

Baseline Data

Create a set of exemplars of each of your

targets and prepare a recording sheet.

Utilize criterion referenced measures.

Always have more than one measurement

Check the reliability of the baseline data

Select research/clinical design

Research/Clinical Designs

ABA designs

Test, treat and test

ABAB designs

Test, treat, test and treat

Time-Series designs

Establish stable baseline

Begin treatment

Measure treatment results

Multiple-Baseline designs

Have a number of different baselines

Each baseline must be independent of the others

Only treat one variable

Requirements

Reliable

Valid

Responsive

Universal

Unbiased

Is it reliable?

Will the instrument measure consistently across:

Different testing situations?

Test-retest reliability

Different judges?

Inter-rater reliability

Is it valid?

Is the instrument

being used to

measure the kind of

data for which it

was intended?

Is it responsive?

The instrument should be equally sensitive, whether a

characteristic is present or absent.

Must measure both:

False-negatives:

You thought it was intact, but it was torn.

False-positives:

You thought it was torn, but it was intact.

Is it universal?

The investigator should

employ a widely used data

collection instrument, which

helps minimize reporting bias

because the data can then be

compared with other published

literature.

Is it unbiased?

There should be no difference between the true value

and the value that an investigator actually obtains

other than a difference caused by sampling variability.

Sampling Methods

Systematic Sampling

Stratified Sampling

4. Cluster Sampling

5. Convenience Sampling

6. More complex sampling

status, and etc

Variables that yield observations that can be measured are

considered to be quantitative variables. Examples of

quantitative variables are weight, height, and age

Quantitative variables can further be classified as discrete or

continuous

Variables types

1.

2.

3.

4.

income category)

Continuous variables (e.g., Age, income,

weight, height, time to achieve an outcome)

Discrete variables (e.g.,Number of Children in

a family)

Binary or Dichotomous variables (e.g.,

response to all Yes or No type of questions)

Scale of Data

1. Nominal: These data do not represent an amount or quantity (e.g.,

Marital Status, Sex)

2. Ordinal: These data represent an ordered series of relationship (e.g.,

level of education)

3. Interval: These data is measured on an interval scale having equal

units but an arbitrary zero point. (e.g.: Temperature in Fahrenheit)

4. Interval Ratio: Variable such as weight for which we can compare

meaningfully one weight versus another (say, 100 Kg is twice 50 Kg)

TYPES OF VARIABLE

independent

dependent

intermediate

confounding

Independent Variable

The characteristic being observed and/or

measured that is hypothesized to influence an

event or outcome (dependent variable).

NOTE

The independent variable is not influenced

by the event or outcome, but may cause it

or contribute to its variation.

Dependent Variable

A variable whose value is dependent on

the effect of other variables (ie.,

independent variables) in the

relationship being studied. Synonyms:

outcome or response variable.

NOTE

an event or outcome whose variation we

seek to explain or account for by the

influence of independent variables.

Intermediate Variable

A variable that occurs in a causal pathway from

an independent to a dependent variable.

Synonyms: intervening, mediating

NOTES

it produces variation in the dependent

variable, and is caused to vary by the

independent variable.

such a variable is associated with both the

dependent and independent variables.

Confounding Variable

A factor (that is itself a determinant of the

outcome), that distorts the apparent effect of a

study variable on the outcome.

NOTE

such a factor may be unequally distributed

among the exposed and the unexposed, and

thereby influence the apparent magnitude and

even the direction of the effect.

Organizing Data

1.

2.

3.

4.

5.

6.

7.

8.

9.

Frequency Table

Frequency Histogram

Relative Frequency Histogram

Frequency polygon

Relative Frequency polygon

Bar chart

Pie chart

stem-and-leaf display

Box Plot

Frequency Table

Suppose we are interested in studying the number of

children in the families living in a community. The

following data has been collected based on a random

sample of n = 30 families from the community.

2, 2, 5, 3, 0, 1, 3, 2, 3, 4, 1, 3, 4, 5, 7, 3, 2, 4, 1, 0, 5, 8, 6,

5, 4 , 2, 4, 4, 7, 6

Organize this data in a Frequency Table!

Frequency Table

X=No. of Children Count

(Freq.)

Relative Freq.

2/30=0.067

3/30=0.100

5/30=0.167

5/30=0.167

6/30=0.200

4/30=0.133

2/30=0.067

2/30=0.067

1/30=0.033

Frequency plot

Frequency Table

Now suppose we need to construct a similar frequency table for the

age of patients with Heart related problems in a clinic.

The following data has been collected based on a random sample of

n = 30 patients who went to the emergency room of the clinic for

Heart related problems.

The measurements are: 42, 38, 51, 53, 40, 68, 62, 36, 32, 45, 51, 67,

53, 59, 47, 63, 52, 64, 61, 43, 56, 58, 66, 54, 56, 52, 40, 55, 72, 69.

Frequency Table

Age Groups

Frequency

Relative

Frequency

32 -36.99

2/30=0.067

37- 41.99

3/30=0.100

42-46.99

4/30=0.134

47-51.99

3/30=0.100

52-56.99

8/30=0.267

57-61.99

3/30=0.100

62-66.99

4/30=0.134

67-72

3/30=0.100

Total

n=30

1.00

Where is the heart of distribution?

1. Mean

2. Median

3. Mode

Empirical Rule

For a Normal distribution approximately,

a) 68% of the measurements fall within one standard

deviation around the mean

b) 95% of the measurements fall within two standard

deviations around the mean

c) 99.7% of the measurements fall within three

standard deviations around the mean

Prerequisite Skills

Fundamental concepts of measurement

Scales of measurement

Distribution, central tendency, variability,

probability

Disease prevalence and incidence

Disease outcomes (eg, fatality rates)

Associations (correlation or covariance)

Health impact (eg, risk differences and ratios)

Sensitivity, specificity, predictive values

Scales of Measure

value: gender, race, color, city

Ordinal - qualitative classification which can

be rank ordered: socioeconomic status of

families

Interval - Numerical or quantitative data: can

be rank ordered and sizes compared :

temperature

Ratio - interval data with absolute zero value:

time or space

Mean

Variability, Probability

Mean

Median

Mode

Standard deviation

Statistical Significance p < .01

Confidence Interval

Statistical Significance

Type I and Type II errors

Null Hypothesis = Ho

Ho True

Ho False

Reject Ho

Type I error

Correct

decision

Do Not Reject

Ho

Correct

decision

Type II error

The Statistics Homepage

http://www.statsoftinc.com/textbook/sta

thome.html

Incidence

Prevalence

any point in time

2% of the population has diabetes

Incidence

develops disease during interval

0.2% or 2 per 1000 new cases per year

Sensitivity, Specificity

sensitivity =

a / (a+c)

specificity =

d / (b+d)

Patients

with

disease

Test is

positive

Test is

negative

Patients

without

disease

Predictive Value

Positive predictive value

= a / ( a+b)

Negative predictive

value = d / (c+d)

Post-test probability of

disease given positive

test = a / (a+b)

Post-test probability of

disease given negative

test = c / (c+d)

Patients

with

disease

Test is

positive

Test is

negative

Patients

without

disease

An Introduction to Information Mastery

http://www.poems.msu.edu/InfoMastery/defau

lt.htm

Diagnosis

Sensitivity and specificity

Predictive values

Likelihood ratios

InfoRetriever

Areas in which bias can occur

Systematic error in . . .

Allocation

Response

Assessment

Allocation or Susceptibility Bias

Can occur when patient assignments to a trial

group are influenced by an investigators

knowledge of the treatment to be received.

Can result in

treatment groups

that have different

prognoses.

Allocation or Susceptibility Bias

Treatment groups must have similar

prognoses, which is achieved by:

Randomization of patients

Prospective evaluation of patients

Well-defined inclusion and exclusion criteria

Occurs when patients

are assigned to

treatments by means

of a mechanism that

prevents both the

patients and the

investigator from

knowing which

treatment is being

assigned.

Benefits of Randomization

Prevents the systematic introduction of bias.

Minimizes the possibility of allocation bias.

Balances prognostic factors for treatment groups.

Improves the validity of statistical tests used to

compare treatments.

Response & Assessment/Recording Bias

Can occur when a patient reports a treatment

response or when an investigator assesses that

responseeither person can be influenced by

knowing the treatment.

A patient or an investigator may have a

preconceived idea of which treatment is better.

The patient may also want to please the

investigator.

Blinding

To minimize Response & Assessment/Recording Bias

Single Blind (patient blinded): protects against

response bias.

Double Blind (patient and investigator blinded):

protects against assessment/recording bias as well

as response bias.

Transfer bias

Occurs when patients are lost to follow-up.

Must be minimized.

Performance bias

Can occur with a single surgeon or with

multiple surgeons.

Confounding Example

Relationship between coffee and

pancreatic cancer, BUT

Smoking is a known risk factor for

pancreatic cancer

Smoking is associated with coffee

drinking but it is not a result of coffee

drinking.

What is confounding?

If an association is observed between

coffee drinking and pancreatic cancer

or

The coffee drinking and pancreatic cancer

association is the result of confounding by

cigarette smoking.

If you know something is a possible

confounder, in the data analysis use

Stratification, or

Adjustment

Treatment vs. Observational

Prospective vs. Retrospective

Longitudinal vs. Cross-sectional

Randomized vs. Non-Randomized

Blinded/Masked or Not

Randomization: Definition

Random Allocation

cannot predict the treatment to be given

Similar Treatment Groups

Randomization tries to ensure that ONE

factor is different between two or more

groups.

Observe the Consequences

Attribute Causality

Types of Randomization

Standard ways:

Random number tables (see text)

Computer programs

NOT legitimate

Birth date

Last digit of the medical record number

Odd/even room number

Types of Randomization

Simple

Blocked Randomization

Stratified Randomization

Simple Randomization

Randomize each patient to a treatment

with a known probability

trends in group assignment

Could have different distributions of a

trait like gender in the two arms

Block Randomization

Insure the # of patients assigned to

each treatment is not far out of balance

Variable block size

gender in the two arms possible

Stratified Randomization

A priori certain factors likely important

(e.g. Age, Gender)

Randomize so different levels of the

factor are balanced between treatment

groups

Cannot evaluate the stratification

variable

Stratified Randomization

For each subgroup or strata perform a

separate block randomization

Common strata

account in the data analysis!

Outline

What is Randomization?

Randomized Study Design

Experimental vs. Observational

Non-Randomized Study Design

Stat Software, Books, Articles

Parallel Group

Sequential Trials

Group Sequential trials

Cross-over

Factorial Designs

Parallel Group

Randomize patients to one of k

treatments

Response

Delta or % change from baseline

Repeated measures

Function of multiple measures

Double blind

Randomized

Parallel groups

Two Scenarios

Study 1

to 422 patients who did not have brain cancer. The patients

cell phone use was measured using a questionnaire. The two

groups use of cell phones was similar.

Study 2

transgenic mice. One hundred were exposed for two 30

minute periods a day to the same kind of microwaves with

roughly the same power as the kind transmitted from a cell

phone. The other 100 mice were not exposed. After 18

months, the brain tumor rate for the exposed mice was twice

as high as that for the unexposed mice.

Questions to Consider

How do the two studies differ?

Study 1

Study 2

Questions to Consider

Why do the results of different medical

studies sometimes disagree?

on human beings?

Questions to Consider

Suppose a friend recently diagnosed with

brain cancer was a frequent cell phone

user. Is this strong evidence that frequent

cell phone use increases the likelihood of

getting brain cancer?

_____________ _____________.

You should rely on reputable research studies,

not anecdotes.

Observational Study

explanatory variables for the sampled subjects without

imposing any treatments

Example:

Experiment

called treatments) to subjects (also called experimental

units) and then observes outcomes on the response

variable.

Treatments correspond to values of the explanatory

variable

Example:

Retrospective

This is sometimes done to find risk factors for certain

diseases

Cross-Sectional

the population at the current time

Prospective

followed into the future

Observational Studies

In an observational study, there can always be

lurking variables affecting the results.

This means that observational studies can

_________ show causation.

It is easier to adjust for lurking variables in an

experiment.

In general, we can study the effect of an explanatory

variable on a response variable more accurately

with an experiment than with an observational study.

Disadvantages of Experiments

They can be ____________ to perform on the

subjects in which you are interested.

It can be difficult to monitor subjects to ensure that

they are doing what they are told.

They can take many years, even decades, to

complete.

Results of experiments that use animals do not

______________ to humans.

They are unnecessary the question of interest does

not involve trying to assess _____________.

Observational Studies

Simple Random Sampling (SRS)

one in which each possible sample of that size has the

_______ chance of being selected.

Studies

Stratified Sampling

separate groups, called ________, and then selects an SRS

from each stratum.

Observational Studies

Cluster Sampling

naturally divides into groups, each of which is representative of the

entire target population. In this method, a SRS of groups (or strata)

is taken. Every member of the selected groups is put into the

sample.

Observational Studies

Systematic Sampling

person from the sample frame. The

researcher randomly selects a number

between 1 and k in order to know which

person to select first, then selects every k th

person after this.

Sampling Designs

Simple Random Sampling (SRS)

Each subject has an _______ chance to be in the

sample.

The sample enables us to determine how likely it is

that descriptive statistics (like the sample mean)

fall close to corresponding values for which we

would like to make inference (like the population

mean).

Sampling Designs

Stratified Sampling

each group that you want to compare.

Cluster Sampling

It is less ___________ to implement.

Bias in Sampling

A sampling method is _________ if

population over others.

In other words, the results from the sample are not

representative of the population.

Types of Bias

Undercoverage

population

Nonresponse bias

participate or fail to answer some questions

Response bias

question wording or the way the interviewer asks the questions is

confusing or misleading

Result in Bias

Convenience Samples

Control group

Enables us to control the __________ _______

The placebo effect occurs when patients seem to improve

regardless of the treatment they receive.

Randomization

treatments to the subjects

Balances the group on variables that you know affect the

response

Balances the group on _________ variables that may be

unknown to you

Blinding

_________-blind: subjects do not know the

treatment assignment

_________-blind: neither the subjects nor those

in contact with the subjects know the treatment

assignment

Example

high blood pressure. To determine the effectiveness of the drug,

the company conducted an experiment in which subjects with a

history of high blood pressure were treated with the new drug.

high blood pressure into two groups. Group A was treated with

the new drug as before. Group B received the most popular drug

on the market at that time. The subjects were unaware of which

treatment they received. 60% of the patients in Group A

improved, while 63% of the patients in Group B improved.

Example

one study used 429 men and women who were 18 or older and had

smoked 15 cigarettes or more per day in the previous year. They were

all highly motivated to quit and in good health. They were assigned to

one of two groups: one group took an antidepressant called Zyban,

while the other group did not take anything. At the end of a year, the

study observed whether each subject had successfully abstained from

smoking.

Comparative Experiments

Randomization ensures that the groups of subjects

are similar in all respects before the treatments are

applied.

Using a control group for comparison ensures that

external influences operate equally on both groups.

If the groups are large enough, natural differences in

subjects will average out.

This means that there be little difference in the results

for the groups unless the treatments themselves

actually cause the difference.

Observational studies can also have control groups.

The cases are people who have a certain disease or

condition, and the controls are people who do not have the

disease.

Their purpose is to see if one of the explanatory variables is

related to the disease.

_________ from the beginning of these notes is an example

of a case-control study.

Important Points

Types of studies:

Sampling designs:

Potential sources of bias:

Undercoverage

Response bias

Nonresponse bias

Convenience sampling

Elements of good experiments:

Important Points

If a group is underrepresented in the sample, we cannot

make inference about it.

We must be careful when interpreting the results of

observational studies.

For comparison of several treatments to be valid, you must

apply all treatments to similar groups of experimental units.

Interesting questions are usually pretty tough to answer. This

is due in part to the fact that no single experiment or

observational study can determine causation.

Write the study!

Describe & classify the

variables.

Instruments for measure?

Bias?

Prepare to analyze data!